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FDA Briefing Document . EUA amendment request for Pfizer-BioNTech COVID-19 Vaccine for use in children 5 through 11 years of age
- COVID-19 Vaccines | FDA - U.S. Food and Drug Administration
FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for...
- FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in ...
Today, the U.S. Food and Drug Administration authorized the...
- COVID-19 Vaccines | FDA - U.S. Food and Drug Administration
19 Οκτ 2022 · In children 6 months to 5 years of age, a two-injection primary series of mRNA-1273 at a dose of 25 μg had an acceptable safety profile and elicited immune responses that were consistent with ...
9 Νοε 2021 · A Covid-19 vaccination regimen consisting of two 10-μg doses of BNT162b2 administered 21 days apart was found to be safe, immunogenic, and efficacious in children 5 to 11 years of age....
Our near–real-time monitoring results for 20 prespecified health outcomes in the pediatric population provide reassuring real-world evidence of the safety of the BNT162b2 COVID-19 vaccine in children and adolescents.
FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age. The FDA amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and...
9 Μαρ 2022 · Two-dose mRNA COVID-19 vaccination was associated with lower risks of SARS-CoV-2 infections with or without symptoms, symptomatic SARS-CoV-2 infections, hospitalizations due to COVID-19–related illnesses, and multisystem inflammatory syndrome in children. ORs were calculated using random-effects model. IV indicates inverse variance. Figure 3.
29 Οκτ 2021 · Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of...